NCT01476306

Brief Summary

The investigators will conduct a two-arm, parallel group, randomized comparative effectiveness study across two sites to increase specialty access and improve care for individuals with Parkinsonism and their caregivers. Twenty individuals with Parkinsonism will be recruited from Johns Hopkins University and the University of Rochester (approximately ten from each site). They will then be randomized to either continue their usual in-person care with a specialist or to receive care with their specialist via telemedicine in their home. Following an in-person baseline/screening visit, approximately ten individuals in the first arm (virtual house calls) will receive three visits with a movement disorder specialist via telemedicine (using web-based video conferencing) in their home. Approximately ten individuals in the second (control) arm will receive three in-person visits at an academic medical center with the same specialists. Approximately two weeks after the completion of each clinical visit, a nurse or coordinator will call the patient to call to address any questions or ensure appropriate understanding of the recommendation (for both telemedicine and control arms). Overall, the study - consistent with a national priority for comparative effectiveness research - will compare the use of telemedicine to manage Parkinsonism to usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

December 11, 2017

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

November 15, 2011

Last Update Submit

December 7, 2017

Conditions

Keywords

feasibilityeffectivenessParkinson disease carecare via telemedicine

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    Percentage of visits completed as scheduled, number of individuals in telemedicine arm who require in-person visit, number of in-person visits required by individuals in telemedicine arm, proportion of completed telemedicine visits versus in-person visits

    7 months

Secondary Outcomes (2)

  • Clinical Benefits

    7 months

  • Economic impact

    7 months

Study Arms (2)

In-patient care

PLACEBO COMPARATOR
Other: Usual care

Telemedicine care

EXPERIMENTAL
Other: Telemedicine

Interventions

Patient will receive care using HIPAA-compliant web-based videoconferencing rather than their usual in-patient care.

Telemedicine care

Patients in this group will receive care as they usually do with the physician.

In-patient care

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The principal eligibility criteria for participants are the following: age greater than 30, clinical diagnosis of idiopathic Parkinsonism, ability to converse in English, ability and willingness to provide informed consent and complete study requirements, and access to a computer with broadband internet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Medical Institutes

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • Dorsey ER, Venkataraman V, Grana MJ, Bull MT, George BP, Boyd CM, Beck CA, Rajan B, Seidmann A, Biglan KM. Randomized controlled clinical trial of "virtual house calls" for Parkinson disease. JAMA Neurol. 2013 May;70(5):565-70. doi: 10.1001/jamaneurol.2013.123.

MeSH Terms

Conditions

Parkinson Disease

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2011

First Posted

November 22, 2011

Study Start

November 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

December 11, 2017

Record last verified: 2017-12

Locations